System and method for marking body cavities

ABSTRACT

A surgical method, including inserting an internal viewing device via a ureter into a first calyx of a kidney, inspecting the first calyx with the internal viewing device, and determining whether the first calyx contains one or more stones. If the first calyx does contain one or more stones, it is marked with a first marking material, but if the first calyx does not contain one or more stones, it is marked with a second marking material different from the first marking material.

PRIORITY

This application is a continuation of U.S. patent application Ser. No.11/070,813, filed Mar. 2, 2005, which is incorporated by reference inits entirety herein.

BACKGROUND

Surgeons are often called upon to inspect internal body cavities todiagnose or remedy a medical condition. For example, a surgeon mayinspect the calices of a patient's kidney to search for and removekidney stones.

In the case of kidney inspection and stone removal, the surgeon may needto inspect each of multiple calices of the kidney. FIG. 1 illustrates atypical kidney 10 that is representative of a kidney that a surgeon mayneed to inspect. As is shown in FIG. 1, the kidney 10 includes an outercapsule 12 that surrounds a renal cortex 14 in which a plurality ofminor calices 16 are formed. Each of the minor calices 16 may extendfrom a major calyx 18 that, in turn, extends from the renal pelvis 20.The renal pelvis 20 is connected to the ureteropelvic junction 22, whichleads down to the ureter 24.

To inspect the kidney 10, the surgeon will normally insert a viewingdevice, such as an endoscope, into each of the calices 16 of the kidney10 to enable visual inspection of each calyx for stones. Such a viewingdevice may be inserted into the kidney via the urinary tract.Fluoroscopy may also be used during such a procedure to aid the surgeonin positioning the viewing device in the desired portion of the kidney10.

It is common for surgeons to use a top-to-bottom approach wheninspecting the kidney 10. In such a procedure, the surgeon checks afirst calyx 16, determines whether it contains any stones, and, assumingit does not, checks the next calyx. When a stone is discovered, it isfragmented, if necessary, and removed from the calyx 16 using aretrieval device. This process continues from the top 26 of the kidney10 to the bottom 28 of the kidney until each calyx 16 has been inspectedand every stone or stone fragment has been removed. During the process,the surgeon or the surgical staff tracks which calices 16 have beeninspected in an effort to ensure that each calyx is checked.

Because there may be many different calices 16 to inspect and becausethe position of the viewing device can only be inferentially determinedfrom the images captured by the viewing device and any capturedfluoroscopic images, it is often difficult for the surgeon to know withany certainty whether a given calyx has or has not been inspected. As aresult, the surgeon may revisit one or more calices one or more times toensure that it has been checked and does not contain any stones. This“double-checking” lengthens the time required to complete the procedure,thereby increasing risk and/or discomfort to the patient.

Even in cases in which the surgeon and staff are careful in keepingtrack of which calices 16 have been inspected, it is possible for themto make a mistake that results in one or more calices not beinginspected. In such a case, one or more stones or stone fragments mayremain which can act as seeds for further stone formation.

In cases in which a stone must be fractured before being removed, forinstance if the stone is too large to be removed as a single piece,lithotripsy may be performed to break the stone into smaller fragments.When lithotripsy is performed, it is possible for a stone fragment to bepropelled into a calyx 16 that has already been checked. If thishappens, one or more stones or stone fragments may remain which, again,can act as seeds for further stone formation.

SUMMARY

Disclosed are systems and methods for marking a body cavity. In oneembodiment, a system includes means for inspecting a body cavity, andmeans for visibly marking the body cavity so as to convey visualinformation regarding the body cavity.

In one embodiment, a method includes inspecting a body cavity, andmarking the body cavity with a marking material to provide a visualindication regarding the cavity.

In one embodiment, a marking material for marking a body cavity includesa radiopaque contrast agent that is viewable through fluoroscopy, and acolored dye that is viewable using an internal viewing device.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosed system and method can be better understood with referenceto the following drawings. The components in the drawings are notnecessarily to scale.

FIG. 1 is a schematic cross-sectional view of a kidney.

FIG. 2A is a schematic cross-sectional view of a kidney, illustratinginspection of a first calyx using a viewing device.

FIG. 2B is a schematic cross-sectional view of a kidney, illustratingmarking the first calyx with a marking material.

FIG. 2C is a schematic cross-sectional view of a kidney, illustratinginspection of a second calyx using a viewing device.

FIG. 2D is a schematic cross-sectional view of a kidney, illustratingremoval of a stone from the second calyx using a retrieval device.

FIG. 2E is a schematic cross-sectional view of a kidney, illustratingmarking the second calyx with a marking material.

FIG. 3A is a schematic cross-sectional view of a kidney, illustratingmarking a third calyx with a marking material.

FIG. 3B is a schematic cross-sectional view of a kidney, illustratingremoval of a stone from the third calyx using a retrieval device.

FIG. 4 is a schematic cross-sectional view of a kidney, illustratingfilling of a group of calices with a first marking material, and filinga separate calyx with a second marking material.

DETAILED DESCRIPTION

As is described in the foregoing, it can be difficult to keep track ofwhich of multiple body cavities have or have not been inspected during asurgical procedure. As is discussed in the following, however, theprogress of such inspection can be clearly indicated using a markingmaterial. By way of example, such a marking material can be used to markone or more cavities that have already been inspected. Alternatively, amarking material can be used to mark one or more cavities of interest,for example that contain an object to be removed. In a furtheralternative, a first type of marking material can be used to markcavities of a first type (e.g., that contain objects to be removed) anda second type of marking material can be used to mark cavities of asecond type (e.g., that contain no objects to be removed). The markingmaterial contains a marking substance that can be viewed with a viewingdevice and/or that can be viewed fluoroscopically. In the former case,the marking substance may comprise a dye. In the latter case, themarking substance may comprise a contrast agent.

Referring now to the drawings, in which like reference numerals identifycorresponding components, FIGS. 2A-E illustrate various steps in anembodiment of a method for inspecting a plurality of internal bodycavities. In the example of FIGS. 2A-2E, the body cavities comprisecalices of a kidney that are to be inspected for kidney stones. Althougha kidney application is shown in the figures and is described in detailherein for purposes of example, the systems and methods of thisdisclosure can be applied to other internal body cavities. Therefore,the present disclosure is intended to cover applications beyond kidneyinspection and stone removal.

Beginning with FIG. 2A, illustrated is the kidney 10 first described inrelation to FIG. 1. As is described above, the kidney 10 comprises aplurality of calices 16 that may comprise kidney stones that are to beremoved (none visible in the view of FIG. 2A). While the bodies of someof the calices 16 are visible in FIG. 2A, only the openings of othercalices are visible (indicated by circles in FIGS. 2A-2E).

As is illustrated in FIG. 2A, an internal viewing device 30 has beeninserted into the kidney 10 via the ureter 24. By way of example, theviewing device 30 comprises a ureteroscope that has been insertedthrough a ureteral access sheath 32 that has been inserted into theurinary tract via the external meatus. Although use of an access sheath32 is depicted in FIG. 2A, the viewing device 30 could, alternatively,be inserted through the urinary tract without the access sheath. Use ofthe access sheath 32, however, simplifies insertion and removal of theviewing device 30, particularly in cases in which the viewing devicemust be repeatedly inserted removed, as when removing multiple stonefragments. In alternative embodiments, the viewing device 30 can beintroduced into the kidney 10 using other methods, for instancepercutaneously.

With further reference to FIG. 2A, the viewing device 30 has beenmaneuvered into a first calyx 34 of the upper portion of the kidney 10.That calyx 34 may, for example, be a suitable calyx to start with in atop-to-bottom inspection procedure, such as that described in theforegoing. As is shown in FIG. 2A, the calyx 34 is clear of any stonesor other objects that would require removal. Because of this, no furtheraction is required in relation to the calyx 34, and the surgeon may moveon to the next calyx 16 of the kidney 10.

As is described above, it can be difficult for a surgeon or the surgicalstaff to keep track of which calices 16 have or have not been inspected.To avoid this problem, the surgeon can mark the calyx 34 prior to movingon to the next calyx 16. By marking the calyx 34 in this manner, thesurgeon can readily determine that he or she has already inspected thatcalyx and understand that no further inspection of the calyx isnecessary. In some embodiments, marking can be achieved by filling thecalyx 34 with a marking material. Such a procedure is illustrated inFIG. 2B. As is indicated in that figure, the calyx 34 has been filledwith a marking material 36. Although the entire calyx 16 is shown filledwith that marking material 36, the calyx (or other cavity) could bemarked by filling only a portion of the calyx with the marking material.For example, the marking material 36 could be used to fill just theentrance to the calyx 34, if desired.

The marking material 36 can be deposited using various different devicesand techniques. In some embodiments, the marking material 36 is injectedinto the calyx 34 (or other cavity) using a working or irrigationchannel of the viewing device 30. In other embodiments, the markingmaterial 36 is delivered using a separate catheter that is insertedthrough the urinary tract (not shown). In still further embodiments, themarking material 36 is percutaneously injected into the desired siteusing an external injection device, such as a syringe.

Irrespective of the manner in which the marking material 36 isdeposited, the marking material contains a marking substance that isvisible using one or both of the viewing device and fluoroscopy. In someembodiments, the marking material 36 comprises one or more dyes thatenable the surgeon to readily identify the marking material when viewingthe kidney interior using the viewing device 30. Suitable dyes include,for example, methylene dyes, such as methylene blue and methylene red.When such a dye is used, the surgeon will be able to readily determinethat the calyx 34 has already been inspected upon later returning tothat area of the kidney 10.

In some embodiments, the marking material 36 further or alternativelyincludes a contrast agent that enables identification of the markingmaterial, and the cavity in which it is placed, through fluoroscopy. Theterm “contrast agent” refers to any radiopaque material capable of beingfluoroscopically monitored. The contrast agent can be either watersoluble or water insoluble. Examples of water soluble contrast agentsinclude metrizamide, iopamidol, iothalamate sodium, iodomide sodium, andmeglumine. Examples of water insoluble contrast agents include tantalum,tantalum oxide and barium sulfate, each of which is commerciallyavailable in the proper form for in vivo use. Other water insolublecontrast agents include gold, tungsten and platinum. As with the dye,the contrast agent assists the surgeon in determining which calices 16(or other cavities) have already been inspected.

In some preferred embodiments, the marking material 36 is in liquid formprior to deposition, but forms a gel after or during deposition. In someembodiments, the marking material 36 can be a temperature-sensitivematerial that is in liquid form below normal body temperature, but thatforms a gel at or above body temperature. Such materials include lowercritical solution temperature materials, such aspolyoxyethylene-polyoxypropylene (PEO-PPO) block copolymers. When such amaterial is used, it can be delivered to the calyx 34 in liquid form,and then transition into a gel as it is heated by the kidney 10.Alternative temperature-sensitive materials include those that are inliquid form at or above normal body temperature, but form a gel belowbody temperature. In such a case, the material can be deposited withinthe calyx 34 and cooled to form a gel. Examples of such materialsinclude gelatin materials.

In other embodiments, the marking material 36 comprises two separatecomponent that, when mixed, form a gel. One example of such materialsare those that include crosslinkable polymers that form a gel whencontacted with a crosslinking agent. Crosslinkable polymers that may besuitable for use in the invention include both ionically crosslinkableand non-ionically crosslinkable polymers. Crosslinking agents that maybe employed include both ionic crosslinking agents and non-ioniccrosslinking agents. Ionically crosslinkable polymers include anioniccrosslinkable polymers and cationic crosslinkable polymers that may beused in conjunction with anionic crosslinking agents and cationiccrosslinking agents, respectively.

Irrespective of the type of marking material 36 that is used, themarking material is a temporary implant that it is automatically ormanually removed once it is no longer needed to identify the calyx 34(or other cavity). For example, in cases in which the marking material36 is a temperature-sensitive material, the material will slowly degradewithin the kidney and be excreted. Optionally, the speed with which thetemperature-sensitive gel breaks down can be increased by either coolingor heating the marking material 36, depending upon whether the materialforms a gel at higher or lower temperatures.

In cases in which the marking material 36 comprises two separatecomponents that together form a gel, breakdown of the marking materialcan, for example, be achieved by providing a third material thatdegrades the gel. For instance, if the marking material 36 includes acrosslinkable polymer, a suitable de-crosslinking agent may be used todissolve the gel, in which case the material will again be excreted.Suitable de-crosslinking agents include sodium phosphate, sodiumcitrate, inorganic sulfates, ethylene diamine tetraacetic acid andethylene dime tetraacetate, citrates, organic phosphates (e.g.,cellulose phosphate), inorganic phosphates (e.g., pentasodiumtripolyphosphate, mono- and di-basic potassium phosphate, sodiumpyrophosphate), phosphoric acid, trisodium carboxymethyloxy succinate,nitrilotriacetic acid, maleic acid, oxalate, polyacrylic acid, sodium,potassium, calcium, or magnesium ions.

In still other embodiments, the gel may be removed by drawing the gelout of the calyx using a lumen of the viewing device or a separatecatheter.

Although the marking material 36 may, in some cases, naturally degradeand be excreted over time, the marking material will remain in place forat least the duration of the inspection procedure. Therefore, as thesurgeon moves on to other calices 16 (or other cavities), the markingmaterial 36 will continue to provide a visual marker of where thesurgeon has already been.

Referring now to FIG. 2C, the surgeon has manipulated the viewing device30 such that it is positioned for insertion into a second calyx 38(which extends into the page in FIG. 2C). Assuming that the second calyx38 comprises a stone (not visible in FIG. 2C), the surgeon can identifythe stone using the viewing device 30, and then remove it. Referring toFIG. 2D, the surgeon has removed the stone 40 using a retrieval device42. By way of example, the retrieval device 42 is inserted through aworking channel of the viewing device 30. In such a case, the retrievaldevice 42 and the viewing device 30 can be withdrawn from the bodytogether (e.g., via the access sheath 32) to remove the stone 40.Alternatively, the retrieval device 42 can be inserted into the kidney10 separate from the viewing device 30.

After the stone 40 has been removed, and assuming no other stones existin the second calyx 38, the calyx can be marked with the markingmaterial 36 in similar manner to that described above in relation to thefirst calyx 34. Accordingly, the second calyx 38 can, for example, befilled with the marking material 36 as is indicated in FIG. 2E. Again,such filling can be accomplished using a working or irrigation channelof the viewing device 30, a separate catheter, or a percutaneousinjection device.

The above-described process can continue in similar manner until everycalyx 16 has been inspected, all stones have been removed, and allinspected calices have been marked. In such a case, the surgeon canreadily determine that each calyx has been inspected. In cases in whichthe marking material 36 comprises a gel, a further benefit is providedif lithotripsy is performed. Specifically, once a calyx 16, or itsentrance, has been filled with a gel-based marking material, fragmentsthat break off of a stone during lithotripsy will not be able to enterthe calyx. Therefore, the surgeon need not recheck previously-inspectedcalices after lithotripsy.

FIGS. 3A and 3B illustrate an example of a further marking application.Beginning with FIG. 3A, a given calyx 44 comprises a plurality of stones46 that are to be removed. By way of example, the stones 46 comprisefragments of a larger stone that was broken up through lithotripsy.Assuming that the surgeon can only remove one stone 46 at a time, or atleast cannot remove all of the stones at once, the surgeon may need toreturn to the calyx 44 one or more times after withdrawing the viewingdevice 30. In such a case, it may be difficult for the surgeon torelocate the calyx 44 or distinguish it from other calices 16 of thekidney 10. To aid the surgeon in such relocation, the surgeon can markthe calyx 44 with the marking material 36, as is indicated in FIG. 3A.After marking the calyx 44, the surgeon can then remove the stones 46(e.g., one by one) from the calyx through the marking material 36 usingthe retrieval device 42. In cases in which the marking material 36 is agel, the marking material will stay in place despite the insertion andwithdrawal of the viewing device 30 and/or retrieval device 42.

FIG. 4 illustrates a further marking application. In this application,several of the calices 48 have been marked with a first marking material50 to indicate a first condition, and one calyx 52 has been marked witha second marking material 54 to indicated a second condition. In thisexample, the first condition is absence of any stones and the secondcondition is presence of one or more stones 56. The marking material 50is distinguishable from the marking material 54 in one or more ways. Insome embodiments, the marking material 50 comprises a different coloreddye than the marking material 54 comprises. In such a case, the surgeoncan distinguish the two types of calices (e.g., those containing stonesand those not containing stones) using the viewing device 30. Inaddition or exception, the marking material 50 comprises a differentconcentration of contrast agent than the marking material 54. In such acase, the surgeon can distinguish the two types of calices from afluoroscopic image.

As is indicated in FIG. 4, each of the calices 48 extends from a majorcalyx 58. In such a case, in which the cavities to be marked compriseall of the cavities of a given group or branch of cavities, the entirecalyx 58 can be filled with the marking material 50 to indicate thatthat entire portion of the kidney 10 has already been inspected.

1. A surgical method, comprising: inserting an internal viewing devicevia a ureter into a first calyx of a kidney, and inspecting the firstcalyx with the internal viewing device; determining whether the firstcalyx contains one or more stones, and thereafter: if the first calyxdoes contain one or more stones, marking the first calyx with a firstmarking material, and removing the stones from the first calyx; and ifthe first calyx does not contain one or more stones, marking the firstcalyx with a second marking material different from the first markingmaterial.
 2. The surgical method according to claim 1, furthercomprising: moving the internal viewing device from the first calyx to asecond calyx of the kidney and inspecting the second calyx with theinternal viewing device; determining whether the second calyx containsone or more stones, and thereafter: if the second calyx does contain oneor more stones, marking the second calyx with the first markingmaterial, and removing the stones from the first calyx; and if thesecond calyx does not contain one or more stones, marking the secondcalyx with the second marking material.
 3. The surgical method accordingto claim 1, wherein marking the first calyx with the first markingmaterial includes filling the first calyx with the first markingmaterial.
 4. The surgical method according to claim 1, wherein markingthe first calyx with the first marking material includes filling onlythe entrance of the first calyx with the first marking material.
 5. Thesurgical method according to claim 4, wherein filling the entrance ofthe first calyx with the first marking material prevents objects fromentering the first calyx.
 6. The surgical method according to claim 1,wherein at least one of the first marking material and the secondmarking material comprises a colored dye.
 7. The surgical methodaccording to claim 6, wherein the colored dye includes a methylene dye.8. The surgical method according to claim 6, wherein the first markingmaterial comprises a first colored dye and the second marking materialcomprises a second colored dye different from the first colored dye. 9.The surgical method according to claim 1, wherein at least one of thefirst marking material and the second marking material comprises acontrast agent.
 10. The surgical method according to claim 9, whereinthe first marking material comprises a contrast agent with a firstconcentration and the second marking material comprises a contrast agentwith a second concentration different from the first concentration. 11.The surgical method according to claim 1, wherein at least one of thefirst marking material and the second marking material has an initialliquid form and a subsequent gel form.
 12. The surgical method accordingto claim 11, wherein the at least one of the first marking material andthe second marking material comprises a temperature-sensitive materialthat is in liquid form below normal body temperature and that is in gelform at or above body temperature.
 13. The surgical method according toclaim 1, wherein at least one of the first marking material and thesecond marking material comprises two separate components that whenmixed form a gel.
 14. The surgical method according to claim 13, furthercomprising contacting the gel with a third component that degrades thegel following removal of stones from the kidney.
 15. The surgical methodaccording to claim 1, wherein the inserting an internal viewing devicecomprises inserting an endoscope or ureteroscope.
 16. The surgicalmethod according to claim 1, wherein the removing comprises inserting aretrieval device through a working channel in the internal viewingdevice.
 17. The surgical method according to claim 1, wherein theremoving comprises inserting a retrieval device into the kidney separatefrom the internal viewing device.